AccessGUDID - DEVICE: HarmonyAIR (20845854081805)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: QS0022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QS0022
Company Name: Conmed Corporation

Primary DI Number: 20845854081805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 00724995150068

Device Description: STERIS VV FILTER 2 PK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44979	Surgical plume evacuation system filter	A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	APPARATUS, EXHAUST, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930041	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84601207-6e07-4fc9-982f-29958b81c20f
Public Version Date: November 07, 2022
Public Version Number: 3
DI Record Publish Date: September 11, 2020